Skip to main content
OpenTrials
Completed

NCT Number: NCT01571141

Polyhexamethylene Biguanide Increases the Regression Rate of Human Papillomavirus (HPV) Infection

Human papillomavirus (HPV) infection is a worldwide problem strictly linked to the development of cervical cancer. Persistence of the infection is one of the main factors responsible for the invasive progression and women diagnosed with intraepithelial squamous lesions are referred for further assessment and surgical treatments which are prone to complications. Despite this, there are several reports on the spontaneous regression of the infection.

In this study the investigators will evaluate the effectiveness of a long term polyhexamethylene biguanide (PHMB)-based local treatment in improve the viral clearance reducing the time exposure to the infection and avoiding the complications associated with the invasive treatments currently available.

Women diagnosed with HPV infection were randomly assigned to receive six months of treatment with a PHMB-based gynaecological solution (Monogin®) or to remain untreated for the same period of time.

The administration of Monogin® has been performed every three days for fifteen days and then every fifteen days for the subsequent six months.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pathologic Pap smear
  • positive "high risk" HPV DNA test
  • positive colposcopy examination

Exclusion criteria

  • patients who had undergone wart therapy in the previous six months
  • pregnancy
  • invasive disease
  • immunosuppression
  • previous HPV vaccination

Treatment and study plan

Monogin

Device

Gynaecological solution with polyhexamethylene biguanide, pH 4.0

Primary outcomes

  1. Number of patients with no HPV infection

Sponsors and collaborators

Lead sponsor

AGUNCO Obstetrics and Gynecology Centre

Other

Registry information

Important dates

First posted
Apr 5, 2012
Registry last updated
Apr 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.